Braided catheter assemblies

ABSTRACT

A catheter assembly includes a catheter body extending from a catheter proximal portion to a catheter distal portion. The catheter body includes an inner liner and an outer sleeve. A braid assembly is within the catheter body and between the inner liner and the outer sleeve. The braid assembly includes a first filar array including one or more first filars helically extending around the catheter body in a first direction. The braid assembly further includes a second filar array including one or more second filars helically extending around the catheter body in a second direction opposed to the first direction.

CLAIM OF PRIORITY

This patent application is a continuation of U.S. patent applicationSer. No. 16/889,188, filed Jun. 1, 2020, which application is acontinuation of U.S. patent application Ser. No. 15/598,114, filed May17, 2017, issued on Jul. 7, 2020 as U.S. Pat. No. 10,702,674, whichapplication is a continuation-in-part application and claims the benefitof priority to U.S. patent application Ser. No. 14/900,729, entitled“INTRODUCER SHEATH FOR RADIAL ARTERY ACCESS,” filed on Dec. 22, 2015,issued on Apr. 10, 2018 as U.S. Pat. No. 9,937,321; which application isa 371 national stage application and claims priority to InternationalPatent Application Serial No. PCT/US2014/044519, entitled “INTRODUCERSHEATH FOR RADIAL ARTERY ACCESS,” filed on Jun. 27, 2014; which claimsthe benefit of priority to Provisional Patent Application Ser. No.61/840,764, entitled, “INTRODUCER SHEATH FOR RADIAL ARTERY ACCESS,”filed on Jun. 28, 2013; all of which are hereby incorporated byreference herein in their entireties.

U.S. patent application Ser. No. 15/598,114, filed May 17, 2017, alsoclaims the benefit of priority of U.S. Provisional Patent ApplicationSer. No. 62/338,491, entitled “BRAIDED CATHETER ASSEMBLIES,” filed onMay 18, 2016, which is hereby incorporated by reference herein in itsentirety.

TECHNICAL FIELD

This document pertains generally, but not by way of limitation, tocatheters including instruments used in diagnostic or therapeuticprocedures.

BACKGROUND

Introducer sheaths, guide catheters and the like are used for diagnosticand therapeutic procedures. Sheaths and guide catheters are used toguide other instruments including catheters into and through thevasculature to one or more locations of interest. Catheters aredelivered through one or more of a sheath or guide catheter, and areoptionally navigated with stylets, guidewires or the like throughvasculature beyond the distal ends of the sheath or guide catheter. Thesheaths and guide catheters are in some examples similarly navigatedthrough the vasculature (e.g., with guidewires).

Delivery through various features of the vasculature including vessels,thrombus, plaques or the like is performed with manipulation of one ormore of these catheters (including one of an introducer sheath, guidecatheter, catheter or the like). Manipulation includes one or more ofaxial pushing of the catheter, for instance from the proximal catheterend toward the distal catheter end; lateral bending of the catheter(e.g., perpendicular to the longitudinal axis of the catheter) tonavigate bends in the vasculature or other passage; and rotation of thecatheter, for instance by rotation of the proximal catheter end tocorrespondingly rotate the distal catheter end.

OVERVIEW

The present inventors have recognized, among other things, that aproblem to be solved can include minimizing kinking of a catheter whileenhancing manipulation characteristics of the catheter including one ormore of pushability, torqueability and flexibility. As a conventionalcatheter is made more flexible (e.g., able to bend and navigate turns ina passage or vessel) the catheter is often becomes more prone tokinking. Further, in some examples conventional catheters includebraiding (e.g., polymer, nitinol, stainless steel or the like) toenhance torqueability. The inclusion of braiding in these examples oftendecreases the kink-resistance of the catheter. Catheter are made morekink-resistant in some examples by including one or more coils (e.g.,one or more of nitinol, stainless steel coils or the like) in thecatheter. The one or more coils increase the kink-resistance of thecatheter but do not provide the torqueability available with braiding.Further still, combining coils and braiding increases the dimensions ofthe catheter and correspondingly consumes valuable space (e.g., lumenspace) otherwise available for the delivery of fluids, catheters,instruments or the like through the catheter or placement of conductors,instruments or other features within the catheter.

The present subject matter can help provide a solution to theseproblems, such as by varying one or more characteristics of structuralfeatures of a catheter including the pairing of braided filars invarious ratios, sizes and pitches (inverse of pics per inch), theinclusion of one or more coils with braiding and the like. In oneexample, the braid includes a first array (X) of filars braided in aleft hand direction and a second array (Y) of filars braided in a righthand direction. The filar counts are varied (e.g., X:Y in an examplebase 16 filar count, 15:1, 14:2, 12:4, 10:6, 8:8, 6:10, 12:4, 14:2, 15:1or the like) to provide the desired degree of torqueability to thecatheter. In other examples, the dimensions of the filars for the firstand second arrays of filars vary. For instance, the dimensions of thefilars in the first filar array (X) are smaller (one or more of widthand height) than the dimensions of the filars in the second filar array(Y). In one example, the dimensions of the filars for the filar arrayhaving the smaller number of filars are relatively larger than thedimensions of the filars for the filar array having the greater numberof filars. For example, the increase in dimensions for the fewer filarscan provide increased torqueability in one direction (e.g., left handedrotation) while the greater number of filars can provide increasedtorqueability in the opposed direction (e.g., right handed rotation).

Further, the proposed arrangement increases kink resistance of thecatheter. As previously discussed, conventional braided catheters are(in some examples) relatively prone to kinking with respect to cathetersincluding coils. A catheter including the braided filars describedherein is also resistant to kinking. In one example, the braidingincludes a smaller number of filars in the second filar array with thefilars of the array having relatively larger dimensions (e.g., widths)relative to the dimensions of the second filar array. In some examples,the filars of the second filar array include at least widths an order ofmagnitude greater than the filars of the first filar array. The secondfilar array thereby provides a braided brace extending over and underthe first filar array including the larger number of filars. The braidedbrace is anchored within the catheter, for instance with a reflowedouter sleeve. The braided brace (anchored in place within the catheter)structurally supports the first filar array and enhances maintenance ofthe first filar array in its wound configuration even while the catheteris deflected, for instance in tortuous vasculature. Stated another way,the braided brace (e.g., the second filar array) anchors the first filararray in place within the catheter and provides structural support tothe braid to resist kinking. That is to say, the braided brace providesa support skeleton (cage, frame or the like) within the catheter bodythat is interlaced with the first filar array to minimize (e.g.,eliminate or decrease) kinking otherwise present with the first filararray.

Optionally, the second filar array includes one or more filars havingdimensions approaching or equaling those of a coil. That is to say, thebraiding includes one or more braided coils as part of at least one ofthe filar arrays. The braided coil is another example of a braided bracethat provides support to at least one of the filar arrays to enhancekink resistance while the opposed filar array enhances torqueability.Further, incorporation of filars having dimensions similar to those of acoil (e.g., at least one of the filar arrays includes a coil) minimizesthe profile of the braiding relative to an assembly including a braidwith the coil separately wound over or positioned beneath the braid.

Because the second filar array anchors the first filar array andprovides structural support, in one example because of the largerdimensions of the second filar array filars (e.g., forming a braidedbrace), the pitch (or inversely the pics per inch or PPI) of the braidare readily adjusted to levels that otherwise make the catheter moreprone to kinking. For instance, by increasing the pitch of the firstfilar array (e.g., to 45 degrees or more) torqueability of the catheteris increased. Conversely, the first filar array with the higher pitch(e.g., decreased PPI) is less kink-resistant. The second filar array,braided with the first filar array, structurally supports the firstfilar array and enhances the kink-resistance otherwise minimized by thefirst filar array. In effect the first filar array enhances the kinkresistance for the braiding while the second filar array facilitatesenhanced torqueability.

In another example one or more supplemental coils are included with thebraid. As previously described, the inclusion of a coil in some examplesundesirably consumes space in the catheter or alternately requires thecatheter have a larger outer diameter to accommodate the supplementalcomponents. The present subject matter can help provide a solution tothis problem as well by using a guide recess provided by the braid, forinstance a helical track formed along the braid by one of the first orsecond filar arrays. In one example, the second filar array as describedabove includes a smaller number of filars relative to the first filararray. Optionally, the second filar array includes larger dimensions toprovide additional structural support to the braid while at the sametime promoting torqueability in the ‘weak’ direction of the braid (e.g.,the direction of winding for the limited number of filars in the firstfilar array). The helical track of the second filar array provides aguide recess that extends along the second filar array and is configuredto receive (at least a portion of) the coil therein. Positioning of thecoil within the guide recess minimizes the overall profile of the coilwhile the coil provides additional kink resistance to the catheter. Inan example a catheter including the second filar array providesstructural support to the first filar array and the additional coilcooperates with the second filar array to clamp the first filar arraytherebetween and further enhance the kink resistance of the catheter.

Optionally, a first coil is provided on the proximal face of the firstfilar array (e.g., within a first guide recess) and a second coil isprovided on the distal face of the first filar array (within a secondguide recess). Reflowing of a sleeve over the braid and coil assemblyanchors the at least one coil in place within the guide recess. Further,because the guide recess minimizes the profile of the coil the sleevereadily covers and incorporates the coil with the catheter withoutrequiring a relatively thicker sleeve.

This overview is intended to provide an overview of some of the subjectmatter of the present patent application. It is not intended to providean exclusive or exhaustive explanation of the disclosure. The detaileddescription is included to provide further information about the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 is a front view of a catheter, according to an embodiment.

FIG. 2 is a back view of a catheter, according to an embodiment.

FIG. 3 is a cross-sectional view of a catheter, according to anembodiment.

FIG. 4 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 5 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 6 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 7 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 8 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 9 is a cross-sectional view of a portion of a catheter, accordingto an embodiment.

FIG. 10 is a front view of a catheter, according to an embodiment.

FIG. 11 is a composite cross sectional view of one example cathetertaken along a longitudinal axis (right view) and an orthogonal axis(left view).

FIG. 12 is a composite sectional view of another example catheter havinga partial section along a longitudinal axis (right view) and a crosssection along an orthogonal axis (left view).

While the technology is susceptible to various modifications andalternative forms, specifics thereof have been shown by way of exampleand drawings, and will be described in detail. It should be understood,however, that the application is not limited to the particularembodiments described. On the contrary, the application is to covermodifications, equivalents, and alternatives falling within the spiritand scope of the technology.

DETAILED DESCRIPTION

The embodiments of the present disclosure described herein are notintended to be exhaustive or to limit the disclosure to the preciseforms disclosed in the following detailed description. Rather, theembodiments are chosen and described so that others skilled in the artcan appreciate and understand the principles and practices of thepresent disclosure.

All publications and patents mentioned herein are hereby incorporated byreference. The publications and patents disclosed herein are providedsolely for their disclosure. Nothing herein is to be construed as anadmission that the inventors are not entitled to antedate anypublication and/or patent, including any publication and/or patent citedherein.

The catheter examples as described herein can solve the problemsassociated with current catheter technology by providing novel designs,construction and materials. The catheters, described herein, areoptionally used in interventional procedures including access to one ormore vessels or passages (e.g., arteries, veins, vessels, body passagesor cavities and the like). Further, the catheters described hereinfacilitate enhanced deflection, torqueability and other mechanicalcharacteristics of the catheter during navigation while at the same timeminimizing kinking. For instance, where significant arterial tortuosityis encountered such with a radial artery access or a femoral approach onan obese patient, the catheters described herein are configured fornavigation through such vessels. The catheters described herein include,but are not limited to, introducer sheaths, guide catheters, deliverycatheters, or other typically tubular devices used in diagnostic ortherapeutic procedures (e.g., including instruments, fluid deliverypassages, balloons or the like).

In various embodiments, the catheters include a composite built tubefabricated using a wound metal inner layer (a braid assembly) andjacketed with layers of polymer inside and out, for instance an innerliner and outer sleeve, respectively. The metallic inner layer isconstructed with a multi-filar (6-30 filars) helically wound braidstructure. In some embodiments, the filars are swaged, such that one ormore of the filars is partially flat or ovular (e.g., includingrectangular) in cross-section to achieve a tight wire matrix. In otherexamples, the braid assembly is made with one or more non-swaged, round,square or rectangular filars (optionally in combination with otherfilars having the swaged configuration). As described herein, the braidassembly includes filar arrays, for instance first and second filararrays that are helically wound and interlaced.

In various embodiments, the wall thickness of the braid assembly rangesfrom about 0.0005 to 0.020 inches thick. The braid assembly improves themechanical integrity of the catheter, such as compared to current guidecatheters with respect to kinking, buckling, flexibility, radialstrength, and maintaining circularity of the catheter lumencross-section. This improvement is achieved in one example by varyingnumber of filars in each of the filar arrays (e.g., in various ratiosincluding but not limited to, 15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7,8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15 with a total filar count of16 filars).

In another example, the improved mechanical characteristic (orcharacteristics) is achieved by varying dimensions (e.g., dimensions incross section) of one or more of the filars in one or more of thearrays. For instance, in arrays with the ratio 14:2 the first filars (14filars) include first filar dimensions in the cross section such as oneor more of diameter, thickness or width less than correspondingdimensions of the second filars (2 filars). Stated another way, thesecond filars are fewer in number and are larger in at least one crosssectional dimension relative to the first filars. As described herein,the second filars structurally support the more narrow first filars inthe manner of a braided brace, and thereby behave as a frame, skeleton,cage or the like that maintains the first filars in a desiredconfiguration (e.g., without kinking or buckling during deflection).Optionally the second filars include one or more filars, such as coils,interlaced with the first filars. The coils act as a braided brace forthe first filars similar to the second filars previously described. Thefirst filars (and the second filars including the braided brace) provideimproved torqueability to the catheter, while the braided bracestructurally supports the braid assembly and provides at least enhancedkink resistance. The inclusion of a braided brace incorporates theprofile of the brace into the braid assembly and thereby avoids couplingadditional support structures over or beneath the braid assembly withattendant consumption of space (or enlargement of the catheter) avoided.

In still another example, the catheters described herein include a coilwound along the braid assembly, for instance in a guide recess providedby one of the filar arrays. The coil enhances the mechanicalcharacteristics of the catheters. Optionally, the coil extends helicallyalong one or more of the filars including for example the braided brace.The coil and the braided brace cooperate to capture and hold the firstfilars (described above) in place within the catheter. Further,infiltration of the outer sleeve (e.g., a reflowed or shrunk sleeve)into the braid assembly and the optional coils fixes each of the braidedbrace and the coil (optional) in place. The outer sleeve and the braidedbrace capture and hold the first filars in place and minimize (e.g.,eliminate or decrease) kinking of the catheters. Where the coil isincluded along the braid assembly, the coil and the braided brace arecaptured within the outer sleeve (e.g., reflowed) and clamp the firstfilars therebetween. Kinking, buckling or the like of the first filarsis thereby resisted by one or more of the braided brace or the coil incombination with the outer sleeve.

In at least some examples, the catheter of this disclosure alsocomprises an outer sleeve, such as an outer polymer layer and an innerliner, such as an inner polymer layer. In an embodiment, the outerpolymer layer and the inner polymer layer include one or more polymers,such as PTFE, Pebax, or Polyurethane. The polymer layers are attached tothe braid assembly by thermal polymer heat- shrinking or reflow. Thewall thickness of the polymer layers ranges from 1.0 to 3.0 thousandthsof an inch for each layer.

In various embodiments, the catheters include a pre-shaped curve, suchas a curved distal end region. The catheter attains the pre-shaped curveconfiguration by, for instance, heat-setting the metal portion of thecatheter where the curved configuration is specified. The curve retainsits shape in body temperature and over time does not substantiallysoften (e.g., to unintentionally change shape). The guide catheteroptionally includes a soft (low durometer) polymer distal tip, variousdistal curve shapes, a radiopaque distal marker band, a proximal lueradapter or the like.

The catheters described herein range in size from 3 F to 34 F and inlengths from at least 15 cm or more to 205 cm or less. As previouslydescribed, the features, elements and functions described herein as wellas their equivalents are used in a variety of catheters including, butnot limited to, introducer sheaths, guide catheters, catheters includingone or more of instruments or delivery lumens, or the like. That is tosay, the enhancements to each of torqueability, pushability,flexibility, kink-resistance or the like are readily applied to variouscatheter styles and types.

In reference now to the Figures, FIG. 1 shows a front view of a guidecatheter 100, according to an embodiment. FIG. 2 shows a back view ofthe guide catheter 100. FIG. 3 shows a cross-sectional view of the guidecatheter 100 shown in FIGS. 1 and 2 . In an embodiment, the guidecatheter 100 can be configured for introducing interventional cathetersinto the vasculature of a patient.

In an embodiment, the catheter 100 includes a catheter body 102 (e.g., amain tubular shaft with an optional lumen) with a distal end portion(including a distal tip 104 ) and a proximal end portion (including aproximal end 106). The distal tip 104 is on the opposed end of thetubular shaft 102 from the proximal end 106. The distal tip 104 includesat least one layer of polymer. In another example, the distal tip 104includes at least two layers of polymer. Optionally, the distal tip 104includes an inner layer and an outer layer. In one example, the innerlayer of the distal tip 104 includes PTFE. In another example, the outerlayer of the distal tip 104 includes Pebax. In an embodiment, the distaltip 104 has a length of at least 0.05 inches. In another embodiment, thedistal tip 104 has a length of at least 0.02 inches long. In yet anotherembodiment, the distal tip 104 is 0.2 inches long or shorter. In afurther embodiment, the distal tip 104 can be is 0.5 inches long orless.

In various embodiments, the catheter body (e.g., including the tubularshaft 102) includes a main inner structural layer, for instance one ormore of the braid assembly, discrete coil or combinations of the same asdescribed herein. The main inner structural layer includes a helicallyinterlaced braid assembly extending between the proximal end portion andthe distal end portion (e.g., along the entire length or a portion ofthe length of the catheter body). In various embodiments, the braidassembly covers at least a portion of the inner liner of the catheter.The outer sleeve, for instance a shrink tube, reflowed polymer or thelike surrounds the braid assembly and in at least some examplesinfiltrates interstitial spaces of the braid assembly (e.g., betweenfilars, coils, opposed helixes of the braid or the like).

As described herein, the catheter body including the main tubular shaft102 includes an outer layer (e.g., a jacket, such as an outer sleeve).The outer layer optionally includes a polymer. The outer layer surroundsthe braid assembly (e.g., jackets, coats, covers or the like). The outerlayer is fixed (e.g., fixedly coupled) to the braid assembly andoptionally the inner liner through one or more of shrinking of the outerlayer (shrink tubing) or infiltration of the braid assembly andoptionally contacting the inner liner (by reflowing).

In various embodiments, the inner liner of the catheter (e.g., thecatheter body including the main tubular shaft 102) includes a polymer.The inner layer (e.g., the inner liner) extends along and couples withan inner surface of the braid assembly (e.g., jackets, coat or covers orthe like). The inner layer is coupled (e.g., fixedly coupled) to themain inner structural layer through one or more of compression of thebraid assembly onto the liner (e.g., with an outer sleeve including ashrink tube), compression achieved during braiding of the braid assemblyonto the liner, infiltration of the braid assembly by a reflowed outersleeve including contact and coupling of the reflowed polymer with theinner liner.

The main tubular shaft 102 optionally includes a curve, for instance ator near the distal end portion including the distal tip 104 (shown inFIG. 10 ). The curve shape is configured for anatomical conformance. Theshape is optionally formed and heat processed into the main tubularshaft 102, such as in the braid assembly or another metal portion. Inone example, the braid assembly terminates distally prior to the curveof the distal end portion.

In various embodiments, the braid assembly is laminated between theinner layer (inner liner) and the outer layer (outer sleeve), such thatthe lamination does not fuse the outer sleeve and the inner linertogether.

In an embodiment, the catheter is at least 60 cm long and not longerthan 200 20 cm. In another embodiment, the main tubular shaft 102 is atleast 10 cm long and not longer than 300 cm. In still anotherembodiment, the main tubular shaft 102 is at least 30 cm long and notlonger than 250 cm. In a further embodiment, the main tubular shaft 102is at least 50 cm long and not longer than 225 cm.

In an embodiment, the main tubular shaft 102 includes an outer diameterof at least 0.060 inches and not more than 0.115 inches (e.g., the outerdiameter of the outer sleeve when coupled with the remainder of thecatheter body). In another embodiment, the main tubular shaft 102includes an outer diameter of at least 0.060 inches. In a furtherembodiment, the main tubular shaft 102 includes an outer diameter of atleast 0.040 inches. In yet another embodiment, the main tubular shaft102 includes an outer diameter of at least 0.050 inches. In furtherembodiments, the main tubular shaft 102 includes an outer diameter of atleast 0.070 inches, at least 0.080 inches or the like. In still anotherembodiment, the main tubular shaft 102 has an outer diameter of nogreater than 0.115 inches. In further examples, the main tubular shaft102 has an outer diameter including, but not limited to, no greater than0.095 inches, no greater than 0.105 inches, no greater than 0.125inches, no greater than 0.135 inches.

FIG. 4 and FIG. 5 show cross-section views of portions of a catheter100, according to various embodiments. In the example shown, thecatheter 100 includes an inner lumen 400. In other examples, thecatheter is without an open inner lumen. FIG. 5 shows a cross-section ofa portion of the distal tip 104. As seen in FIG. 5 , the guide catheter100 in an example includes one or more apertures 506. In variousembodiments, the catheter body including the main tubular shaft 102includes an aperture 506 extending from the interior of the catheter 100to the exterior of the catheter. In an embodiment, the distal tip 104includes the aperture 506.

FIG. 6 shows a cross-sectional view of a portion of the main tubularshaft 102 along the longitudinal axis of the catheter 100, according toan embodiment. FIG. 7 shows a cross-sectional view from the end of themain tubular shaft 102 (e.g., orthogonal to the longitudinal axis of thecatheter 100). In an embodiment, the catheter body including the maintubular shaft 102 includes the braid assembly 608. The braid assembly608 includes two or filar arrays interlaced in opposed (left and right)directions around the catheter body. As described herein, each of thefilar arrays includes one or more filars including but not limited toflat or ovular (e.g., swaged) filars, coils (circular filars) or thelike. In various embodiments, the braid assembly includes one or morefilars constructed with, but not limited to, metal (stainless steel,Nitinol or the like), polymers, composites or combinations of filarsconstructed with two or more of the materials described herein.

In various embodiments, the braid assembly 608 filars are swaged. Invarious embodiments, the braid assembly component filars includesinclude between at least 2 and 30 filars having a picks per inch(inverse of pitch) of between 30 and 180. In various embodiments, thebraid assembly includes at least 4 filars and not more than 24 filars.In other embodiments, the braid assembly includes at least 8 filars andnot more than 16 filars. In various embodiments, the metallic filars ofthe braid assembly 608 include cross sectional shapes including, but notlimited to, rectangular cross-sections, circular cross-sections, ovularcross-sections, elliptical cross-sections (another example of an oval)or the like. In various embodiments, the braid assembly 608 filars arecoated, for instance with PTFE, prior to braiding into the interlacedconfiguration of the braid.

In an embodiment, the braid assembly 608 includes welded terminations.In an embodiment, the braid assembly 608 includes a distal end having agold coating. In various embodiments, the gold coating ranges from about0.5 mm to 2 mm thick. In other embodiments, the gold coating ranges fromabout 0.4 mm to 2.5 mm thick. In still other embodiments, the goldcoating ranges from 0 .25 mm to 3 mm thick.

In an embodiment, the braid assembly 608 includes thickness (e.g., fromthe braid assembly exterior to the braid assembly interior) that rangesfrom about 0.0015 inches to 0.010 inches. In another embodiment, thebraid assembly 608 includes a thickness of at least 0.0010 inches. Instill another embodiment, the braid assembly 608 includes a thickness ofat least 0.0005 inches. In other embodiments, the main inner braidassembly 608 includes a thickness of no greater than 0.015 inches. Instill other embodiments, the braid assembly 608 includes a thickness ofno greater than 0.020 inches.

As described herein, the catheter body including the main tubular shaft102 includes an outer layer 610, such as an outer sleeve. The outerlayer 610 includes a polymer in at least one example. The outer layer610 extends around (e.g., jackets, covers, coats or the like) at least aportion of the braid assembly 608. In an embodiment, the outer layer 610is at least about 0.001 inches thick and not more than about 0.005inches thick. In another embodiment, the outer layer 610 is least about0.0007 inches thick. In still another embodiment, the outer layer 610 isat least about 0.0005 inches thick. In yet another embodiment, the outerlayer 610 is no more than about 0.007 inches thick. In furtherembodiments, the outer layer is no more than about 0.01 inches thick.

Optionally, the outer layer 610 includes one or more of polymersincluding, but not limited to, Pebax, PTFE, shrink tubing or the like.In another example, the outer layer 610 includes nylon. In anembodiment, the outer layer 610 is coated with a hydrophilic polymer. Inanother example, the outer layer 610 includes at least two layers.Optionally, each of the two layers includes Pebax or one or more of thepolymers described herein. In another example, the outer layer 610 isheat shrinkable to snugly couple form the outer layer 610 onto the braidassembly 608. In yet another example, the outer layer 610 includes areflowable polymer that is heated and reflows around the braid assembly608. Optionally, the reflowed outer layer 610 infiltrates and capturesone or more of the filars (including the braided brace) within the outerlayer 610. As described herein, the outer layer 610 in cooperation withthe braided brace (e.g., a coil, filars as described herein or the like)and an optional discrete coil maintain the braid assembly 608 in aspecified (unkinked) configuration even with significant deflection ofthe catheter 100 (relative to a braid assembly without the structuralsupport described herein).

In an embodiment, the catheter body including the main tubular shaft 102includes an inner liner, such as an inner layer 612. The inner layer 612includes a polymer including, but not limited to, a lubricious polymersuch as PTFE (e.g., to provide strength and facilitate passage ofinstruments through an optional center lumen as shown in FIGS. 6 and 7). The inner layer 612 extents along at least an interior portion of thebraid assembly 608.

In an embodiment, the inner layer 612 is at least about 0.001 inches andnot more than about 0.005 inches thick. In another embodiment, the innerlayer 612 is at least about 0.0007 inches thick. In yet anotherembodiment, the inner layer 612 is at least about 0.0005 inches thick.In another example, the inner layer 612 is no more than about 0.007inches thick. In still another example, the inner layer is no more thanabout 0.01 inches thick. Optionally, the inner layer 612 includes one ormore polymers including, but not limited to, PTFE (described above),nylon, and coated polymers (e.g., coated with a hydrophilic polymer).

In an embodiment, the outer layer 610 (outer sleeve) and the inner layer612 (inner liner) are fused together, for instance through the braidassembly 608 (shown in FIGS. 6 and 8 ). FIG. 8 shows a cross-sectionview of a portion of a main tubular shaft 802 (a portion of the catheterbody), according to an embodiment. FIG. 9 shows a cross-section viewfrom the end of the main tubular shaft 802. In various embodiments, themain tubular shaft 802 include a braid assembly 814. The braid assembly814 is disposed between an optional inner braid assembly 808 (or otherstructural support layer) and the outer layer 810. In another example,the braid assembly 814 is between the outer sleeve (e.g., outer layer810) and the inner liner (e.g., inner layer 812). In yet anotherexample, the braid assembly 814 is disposed within a portion of theouter layer 810. The braid assembly 814 covers at least a portion of theoptional inner braid assembly 808 in another example.

In an embodiment, the filars of the braid assembly 814 includes metal ora polymer including, but not limited to, stainless steel, Nitinol or thelike. In one embodiment, the braid assembly 814 is at least about 0.0005inches thick and not more than about 0.010 inches thick. In anotherembodiment, the braid assembly 814 is at least about 0.005 inches thickand not more than about 0.010 inches thick. In still another embodiment,the braid assembly 814 is at least about 0.0004 inches thick. In afurther embodiment, the braid assembly 814 is at least about 0.0003inches thick. In other embodiments, the braid assembly 814 no more thanabout 0.015 inches thick, no more than about 0.020 inches thick or thelike.

FIG. 10 shows a front view of an example guide catheter 1000 accordingto an embodiment. The guide catheter 1000 includes a distal end curve1016. The distal end curve 1016 is, in one example, configured foranatomical conformance. As described herein, the distal end curve 1016is heat processed and formed of a formable portion of the catheter 1000,for instance in regions including one or more of the braid assembliesdescribed herein, a separate metal feature or the like. The distal endcurve 1016 retains its shape in body temperature and over time does notsubstantially soften and unspecified shape changes of the curve arethereby prevented.

The catheters described herein include a catheter body including a braidassembly having at least first and second interlaced filar arrays, witheach of the filar arrays including one or more respective first andsecond filars extending in opposed helixes. The braid assembly isbetween an inner liner and an outer sleeve. In at least one example, thebraid assembly including interstitial spaces between filars, filararrays and the like, is infiltrated by the outer sleeve.

The braid assembly is constructed with a multi-filar (e.g., 6-30 filars)helically wound interlaced braid structure. In some embodiments, thefilars are swaged, such that one or more of the filars is partially flator ovular (e.g., including rectangular and elliptical) in cross-sectionto achieve a tight wire matrix. In other examples, the braid assembly ismade with one or more non-swaged, round, square or rectangular filars(optionally in combination with other filars having the swagedconfiguration). In one example, the one or more filars one or both ofthe first and second filar arrays include filars approximating thedimensions and characteristics of a coil (e.g., a circular or ovularcross section, material characteristics such as Young's modulus,flexural modulus or the like). One example of a braided brace 1102 isshown in FIG. 11 by the circular (coil) filars as part of the braidassembly 1100 (and shown in the cross-sectional view on the right takenalong the longitudinal axis of the catheter).

In various embodiments, the wall thickness of the braid assembly 1100ranges from about 0.0005 to 0.020 inches thick. The braid assembly 1100improves the mechanical characteristics of the catheter 1101, such ascompared to current guide catheters with respect to kinking, buckling,flexibility, radial strength, and maintaining circularity of thecatheter lumen 1109 cross-section. The braid assembly 1100 of thecatheter also improves characteristics of the catheter including, butnot limited to, one or more torqueability, flexibility, pushability orkink resistance. This improvement is achieved in one example by varyingnumber of filars (e.g., filars, coils or the like) in each of the filararrays 1104, 1106 (e.g., in various ratios including but not limited to,15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7, 5 8:8, 7:9, 6:10, 5:11, 4:12,3:13, 2:14, 1:15 with a total filar count of 16 filars). One example ofa braid assembly 1200 including an unbalanced ratio is shown in FIG. 12that includes a 16 filar count example braid having 14 first filars inthe first filar array 1202 and 2 second filars in the second filar array1204. For illustration purposes interlacing is removed (but present inthe braid assembly).

In another example, the one or more improved mechanical characteristicsare achieved by varying dimensions (e.g., dimensions in cross section)of one or more of the filars in one or more of the arrays. For instance,in arrays with the ratio 14:2 the first filars (14 filars of a firstfilar array) include first filar dimensions in the cross section such asone or more of diameter, thickness or width less than correspondingdimensions of the second filars (2 filars of a second filar array).Stated another way, the second filars are fewer in number and are largerin at least one cross sectional dimension relative to the first filars.The second filars structurally support the more narrow first filars inthe manner of a braided brace, and thereby provide a frame, skeleton,cage or the like that maintains the first filars in a desiredconfiguration (e.g., without kinking or buckling during deflection). Oneexample of a braid assembly 1200 including filars having differentdimensions between the first and second filar arrays 1202, 1204 is shownin FIG. 12 . As shown the second filars (e.g., coils, filars or thelike) of the second filar array 1204 have at least one larger dimensionrelative to the first filars of the first filar array 1202. In oneexample, the second filars have a dimension, such as width, at least oneorder of magnitude larger than the first filars.

Optionally, the second filars include one or more filars, such as coils,interlaced with the first filars. An example of second filars includingcoils (including filars having coil shapes and dimensions) is providedin FIG. 11 . Although a single array 1106 of second filars is shown inFIG. 11 , other examples include multiple arrays of the second filarsinterlaced with a corresponding number of first filar arrays 1104. Theone or more interlaced coils are another example of a braided brace forthe first filars. The first filars (and the second filars including thebraided brace 1102) provide improved torqueability to the catheter,while the braided brace 1102 structurally supports the braid assembly1100 and provides enhanced kink resistance (and optionally otherimproved characteristics including pushability and torqueability). Theinclusion of a braided brace 1102 incorporates the profile of the braceinto the braid assembly and thereby minimizes the inclusion ofadditional support structures (such as coils) over or beneath the braidassembly with attendant consumption of space (or enlargement of thecatheter) avoided.

In still another example, the catheters described herein include a coil1206 wound along the braid assembly 1200, for instance in a guide recess1208 provided by one of the filar arrays 1202, 1204. One example ofdiscrete coils is shown in FIG. 12 by the one or more coils 1206extending along the second filar array 1204. The coil 1206 enhances themechanical characteristics of the catheter 1201. Optionally, the coil1206 extends helically along one or more of the filars including forexample the braided brace 1210. The coil 1206 and the braided brace 1210cooperate to capture and hold the first filars (described above) 1202 inplace within the catheter 1201. Further, infiltration of the outersleeve 1212 (e.g., a reflowed or shrunk sleeve) into the braid assembly1200 and the optional coils 1206 fixes each of the braided brace 1210and the coil 1206 (optional) in place. The outer sleeve 1212 and thebraided brace 1210 capture and hold the first filars 1202 in place andminimize (e.g., eliminate or decrease) kinking of the catheter 1201.Where the coil 1206 is included along the braid assembly 1200, the coiland the braided brace are captured within the outer sleeve 1212 (e.g.,reflowed) and clamp the first filars 1202 therebetween. Kinking,buckling or the like of the first filars is thereby resisted by one ormore of the braided brace 1210 or the coil 1206 in combination with theouter sleeve 1212.

As further shown in FIG. 12 , the catheter 1201 further includes one ormore guide recesses 1208 adjacent to the second filar array 1204. Theone or more faces 1214, 1216 of the second filar array 1204 form theguide recesses 1208. For instance, as shown in FIG. 12 , the secondfilar array 1204 includes proximal and distal faces 1214, 1216. The oneor more guide recesses 1208 follow the helical track of one of the filararrays 1202, 1204 (in the example shown the second array 1204) andoptionally include two guide recesses, one along the proximal face 1214and the other along the distal face 1216 of the second filar array 1204.Because the second filar array 1204 is interlaced with the first filararray 1202 to form the braid assembly 1200 proximal and distal faces1214, 1216 are present where the second filar array 1204 is on theexterior of the braid assembly (e.g., between passes of the first filarsof the first filar array 1202). In at least those zones, the coil (orcoils) 1206 is partially received within the braid assembly 1200 tothereby minimize the space (e.g., outer sleeve 1212 thickness) used tocontain the coils 1206 in the outer sleeve. In one example, the braidassembly 1200 facilitates the inclusion of a discrete coil 1206 and thebenefits to the mechanical characteristics (e.g., kink-resistance or thelike) while minimizing the space needed to retain the coil 1206 in thecatheter 1201. At least a portion of the profile of the coils 1206 isconcealed within the guide recesses 1208 while the remainder is withinthe outer layer 1212. The outer layer 1212 is in one example madethinner with its exterior immediately adjacent to the outer surface ofthe (recessed) coils.

As previously described herein one or more of the ratio of filars,dimensions of filars and components included with the braid assembly1100, 1200 and along the braid assembly are varied to provide specifiedmechanical characteristics for a catheter 1101, 1201. For instance,various ratios and dimensions of filars are used to provide a specifiedtorqueability for the catheter 1101, 1201 and at the same time enhancekink-resistance. One or more optional discrete coils 1206 are optionallyprovided along the braid assembly 1100, 1200, for instance within guiderecesses 1208 of the braid assembly 1200, to further enhance themechanical characteristics of the catheter. Tables 1, 2 and 3 providedherein describe each of the various features of an example braidassembly including, but not limited to, filar ratios between first andsecond filar arrays, filar dimensions, filar shapes, discrete coils andpositioning of the same. These features are chosen and implemented inthe catheter to provide the specified characteristics for a therapeuticor diagnostic procedure.

Table 1 (below) provides one example of a braid assembly including afilar count of 16 total filars. As shown, the ratios between the firstand second filar arrays, and in some examples their cross sectionalshapes, are varied between each of the example braid configurations.Although the smaller filar arrays (e.g., six and under) include theoption for circular filars (e.g., coils or the like), circular filarsare also included in some examples with filar array having larger filarcounts, for instance greater than six filars.

TABLE 1 Structural Braid Configuration (example of 16 filar countbetween arrays, but total filar count is higher or lower in examplessuch as 6, 8, 10, 12, 14, 18, 20, 22, 24, 26, 28, 30 or the like) FirstFilar Array - Second Filar Array - Braid Filar Count (e.g., First FilarArray - Filar Count (e.g., Second Filar Array - Configuration left handhelix) Filar Shape right hand helix) Filar Shape X1 15 flat or ovular 1circular (e.g., coil), flat or ovular X2 14 flat or ovular 2 circular(e.g., coil), flat or ovular X3 13 flat or ovular 3 circular (e.g.,coil), flat or ovular X4 12 flat or ovular 4 circular (e.g., coil), flator ovular X5 11 flat or ovular 5 circular (e.g., coil), flat or ovularX6 10 flat or ovular 6 circular (e.g., coil), flat or ovular X7 9 flator ovular 7 flat or ovular X8 8 flat or ovular 8 flat or ovular X9 7flat or ovular 9 flat or ovular X10 6 circular (e.g., coil), flat orovular 10 flat or ovular X11 5 circular (e.g., coil), flat or ovular 11flat or ovular X12 4 circular (e.g., coil), flat or ovular 12 flat orovular X13 3 circular (e.g., coil), flat or ovular 13 flat or ovular X142 circular (e.g., coil), flat or ovular 14 flat or ovular X15 1 circular(e.g., coil), flat or ovular 15 flat or ovular

Table 2 describes filar configurations including dimensions for each ofthe first and second filar arrays. In some examples, larger filardimensions (e.g., of the second filar array) are paired with smallerfilar dimensions of the other filar array (e.g., the first filar array).Examples of filars having circular cross sections are also providedincluding dimensions between about 0.001 to 0.01 inches. Table 2 furtherqualitatively shows the relative difference between dimensions of thefirst and second filar arrays in the Order of Magnitude column. Asshown, at least some the filar configurations provide one or more of thefilars of one array as at least one order of magnitude larger in adimension, such as width or diameter, relative to the correspondingdimension of the other filars of the other (e.g., second) filar array.

TABLE 2 Filar Configurations (example flat/ovular or coil dimensionsused in some examples with the braid configurations of Table 1) FilarFirst Filar Array - First Filar Array - Filar Second Filar Array -Second Filar Array - Filar Order of Magnitude Difference ConfigurationFilar Shape Dimensions (inches) Filar Shape Dimensions (inches) (e.g.,of width or diameter) Y1 flat or ovular 0.0005 × 0.003 flat or ovular0.002 × 0.015 Yes Y2 flat or ovular 0.0005 × 0.003 flat or ovular 0.002× 0.010 Yes Y3 flat or ovular  0.002 × 0.015 flat or ovular  0.002 ×.0.015 No Y4 flat or ovular  0.002 × 0.015 circular (e.g., coil) 0.001 NoY5 flat or ovular  0.002 × 0.015 circular (e.g., coil) 0.003 No Y6 flator ovular 0.0005 × 0.003 circular (e.g., coil) 0.004 Yes Y7 flat orovular 0.0005 × 0.003 circular (e.g., coil) 0.005 Yes Y8 flat or ovular0.0005 × 0.003 circular (e.g., coil) 0.008 Yes Y9 flat or ovular 0.0005× 0.003 circular (e.g., coil) 0.01 Yes (2 orders of magnitude) Table 2provides an array of example dimensions. Filar Dimensions (flat orovular) vary between thicknesses of 0.0005 to 0.005 and widths of 0.001to 0.030 As described herein, in one example, a filar array with fewerfilars has relatively larger filar dimensions relative to a companionfilar array having a greater number of filars

Table 3 describes the placement of one or more discrete coils with thebraid assembly. Further, the table describes options for positioning ofthe coils within guide recesses, for instance along the one or moreguide recesses 1208 previously shown in FIG. 12 and provided alongsideone of the filar arrays, for instance the second filar array 1204 havinglarger dimensions and correspondingly larger recesses (e.g., having adepth corresponding to the thickness or diameter of the second filars).In various examples, one or more coils are positioned within proximal ordistal guide recesses 1208 (e.g., along the proximal or distal faces1214, 1216 of a filar assembly such as the second filar assembly).

TABLE 3 Discrete Coil (example coils optionally used in some exampleswith the braid configurations of Tables 1 and 2) Proximal or DistalGuide Recess Coil Placement of Coil Relative to Coil Positioning inBraid (Relative to braid filar or filars Configuration Braid (Exterioror Interior) Guide Recess or Recesses providing guide recesses) Numberof Coils Z1 Exterior Yes Proximal 1 Z2 Exterior Yes Proximal and Distal2 Z3 Exterior Yes Distal 1 Z4 Exterior No NA 1 Z5 Exterior No NA 2 Z6Interior No NA 1 Z7 Interior No NA 2 Coil Dimensions: Various including0.001 to 0.010 inches.

A variety of prophetic example catheter configurations are providedherein. The configurations are drawn by assembling one or more of theconfigurations provided in Tables 1, 2 and 3 and provide variation inmechanical characteristics based on the configurations chosen (e.g., theinclusion of a braided brace, such as larger filars in one of thearrays, a coil or the like improve kink-resistance).

The catheter of example 1 includes a braid assembly provided over a PTFEinner liner with an intermediate tie layer provided between the PTFE andthe braid assembly (e.g., to facilitate coupling of the braid assemblyand optionally an outer sleeve with the inner liner). The inner linerhas an outer diameter of about 0.255 to 0.256 inches; the tie layerouter diameter (over the inner liner) is about 0.260 to 0.2605 inches;and the braid assembly outer diameter (over the tie layer) is about0.270 to 0.271 inches. An outer sleeve, such as Pebax or the like, isprovided along the catheter and over the braid assembly.

The catheter of example 2 includes a braid assembly with a discrete coilextending along the braid assembly exterior. The braid assembly includesan 8:8 ratio of first filars to second filars. In one example, the firstfilars have cross sectional dimensions of about 0.002 (thickness) byabout 0.015 (width) inches. The second filars have the same dimensions.In another example, the second filars have the previously describeddimensions (e.g., 0.002×0.015 inches) while the first filars have crosssectional dimensions of about 0.0005 inches by 0.003 inches. In thisexample, the second filars have dimensions an order of magnitude greaterthan the first filars. The braid assembly is provided over a PTFE innerliner with an intermediate tie layer. The inner liner has an outerdiameter of about 0.2555 to 0.2565 inches; the tie layer outer diameter(over the inner liner) is about 0.2585 to 0.259 inches; and the braidassembly outer diameter (over the tie layer) is about 0.261 to 0.2615inches. The coil is loaded over the braid assembly and retainedtherealong with the outer sleeve, such as Pebax or the like. In oneexample, the outer sleeve has a durometer of 55D and an outer diameterof between about 0.280 inches to 0.285 inches. Optionally, an end of thecoil is fixed near the corresponding end of the braid assembly and thecoil is wound around the braid assembly in the same direction (e.g.,from proximal to distal). In another example, the coil is would alongone or more guide recesses of one of the filar arrays as describedherein.

The catheter of example 3 includes a braid assembly having an 8:8 ratioof eight filars for the first filar array and eight filars for thesecond filar array. The braid assembly is provided over a PTFE innerliner and an intermediate tie layer is provided between the PTFE and thebraid assembly (e.g., to facilitate coupling of the braid assembly andoptionally an outer sleeve with the inner liner). The inner liner has anouter diameter of about 0.255 to 0.266 inches; the tie layer outerdiameter is about 0.258 to 0.259 inches; and the braid assembly outerdiameter is about 0.263 to 0.264 inches. The first filars have crosssectional dimensions of 0.0005 (thickness) by 0.003 (width) inches. Thesecond filars have cross section dimensions of 0.002 (thickness) by0.015 (width) inches. The second filars have dimensions an order ofmagnitude greater than the first filars. The braid assembly is braidedat 50 picks per inch, and is encapsulated with a polymer having adurometer of 55D and an outer diameter of about 0.280 to 0.285 inches.

In other examples (related to example 3), the braid assembly has a 14:2or 12:4 ratio with the first filars havin the same dimensions. In thisexample, the picks per inch are optionally increased (e.g., greater than50, for instance to 180 PPI). In still another example, the braidassembly has a 15:1 ratio of first filars to second filars. Each of thefirst and second filars include the same dimensions as those for the 8:8example provided immediately above.

In either of the examples (e.g., ratios of 8:8, 14:2, 12:4, 15:1) thecatheter optionally includes a discrete coil. For instance, in the lastexample including the 15:1 ratio the coil is positioned within a guiderecess formed along the second filar array (e.g., including the singlesecond filar). The guide recess appears in the examples as one or morerifled grooves extending along the braid assembly. In addition toproviding increased kink-resistance, the inclusion of the coil enhancesthe radial strength of the catheter (resistance to collapsing).

The catheter of example 4 includes a braid assembly having a 14:2 ratioof fourteen first filars for the first filar array and two second filarsfor the second filar array. In a similar manner to the previousexamples, the braid assembly is provided over a PTFE inner liner (e.g.,inner sleeve 1107 in FIG. 11 and inner sleeve 1203 in FIG. 12 ) and anintermediate tie layer (e.g., 1103, 1205, respectively) is providedbetween the PTFE and the braid assembly. The inner liner has an outerdiameter of about 0.255 to 0.256 inches; the tie layer outer diameter isabout 0.258 to 0.259 inches; and the braid assembly outer diameter isabout 0.263 to 0.2635 inches. The first filars have cross sectionaldimensions of 0.0005 (thickness) by 0.003 (width) inches. The secondfilars have cross section dimensions of 0.002 (thickness) by 0.015(width) inches and are an order of magnitude greater than the firstfilars. Optionally, the two filars of the second filar array arestaggered 180 degrees apart (e.g., on opposite sides of the catheter) toform a double helix. The braid assembly is braided at 90 PPI, and isencapsulated with a polymer (e.g., outer sleeve 1105) having a durometerof 55D and an outer diameter of about 0.280 to 0.285 inches.

The catheter of example 5 includes a braid assembly having a 15:1 ratioof fifteen first filars for the first filar array and one second filarfor the second filar array. The filars are provided at 160 PPI. In asimilar manner to the previous examples, the braid assembly is providedover a PTFE inner liner and an intermediate tie layer is providedbetween the PTFE and the braid assembly. The inner liner has an outerdiameter of about 0.2555 to 0.256 inches; the tie layer outer diameteris about 0.258 to 0.259 inches; and the braid assembly outer diameter isabout 0.2625 to 0.2635 inches. The first filars have cross sectionaldimensions of 0.0005 (thickness) by 0.003 (width) inches. The secondfilar has cross sectional dimensions of 0.002 (thickness) by 0.015(width) inches and is an order of magnitude greater than the firstfilars.

The second filar array in this example provides at least one guiderecess (e.g., along the proximal or distal faces of the filar array) anda coil is wound along the filar array and positioned within the guiderecess (the recess serves as a guide for placement of the coil). Thecoil is at least partially received within the guide recess and theprofile of the coil is thereby decreased because it is partiallyabsorbed by the filar array and its guide recess. In one example, wherethe coil is wound in a particular direction (e.g., left hand) the secondfilar array is also wound left handed (and the first filar array woundright handed) to ensure placement of the coil within the guide recess.

The braid assembly and the coil are encapsulated with a polymer (outersleeve) having a durometer of 55D and an outer diameter of about 0.280to 0.285 inches. Optionally, the outer sleeve is reflowed multiple time(e.g., at least twice) to remove gas bubbles in the sleeve. The catheterof example 5 has enhanced radial strength and flexibility relative to atleast some of the other examples.

Example 6 includes a selection of catheters including braid assemblieshaving ratios of 15:1, 14:2, 12:4 and so on. The braid assembliesinclude second filars having dimensions approaching or equaling those ofa coil. For instance, filar (coil) diameters of about 0.003 to 0.005inches (e.g., larger than the 0.002×0.015 filars described herein). Thesecond filars of the second filar array are interlaced with the firstfilar array. In one example, the second filars are staggered around thecatheter body, for instance according to the count of the second filars(4 second filars at 90 degree intervals, 3 at 120 degree intervals, 2 at180 degree intervals or the like). Optionally, these catheters and thesecond filar arrays of each are paired with discrete coils that arepositioned within one or more guide recesses of the second filar array.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a composition containing “a compound” includes a mixture oftwo or more compounds. It should also be noted that the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

It should also be noted that, as used in this specification and theappended claims, the phrase “configured” describes a system, apparatus,or other structure that is constructed or configured to perform aparticular task or adopt a particular configuration. The phrase“configured” can be used interchangeably with other similar phrases suchas arranged and configured, constructed and arranged, constructed,manufactured and arranged, and the like.

All publications and patent applications in this specification areindicative of the level of ordinary skill in the art to which thistechnology pertains. All publications and patent applications are hereinincorporated by reference to the same extent as if each individualpublication or patent application was specifically and individuallyindicated by reference.

The technology has been described with reference to various specific andpreferred embodiments and techniques. However, it should be understoodthat many variations and modifications may be made while remainingwithin the spirit and scope of the technology.

VARIOUS NOTES & EXAMPLES

Example 1 can include subject matter such as can include a catheterassembly comprising: a catheter body extending from a catheter proximalportion to a catheter distal portion, the catheter body includes: aninner liner, and an outer sleeve; and a braid assembly within thecatheter body and between the inner liner and the outer sleeve, thebraid assembly includes: a first filar array including one or more firstfilars helically extending around the catheter body in a firstdirection, and a braided brace interlaced with the first filar array,the braided brace extends around the catheter body in a second directionopposed to the first direction, wherein the braided brace anchors andsupports the first filar array.

Example 2 can include, or can optionally be combined with the subjectmatter of Example 1, to optionally include wherein the braided braceincludes a second filar array including one of more second filars.

Example 3 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 or 2 to optionallyinclude wherein the one or more second filars have a second filar widthgreater than a first filar width of the one or more first filars.

Example 4 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-3 to optionally ncludewherein the second filar width is at least one order of magnitudegreater than the first filar width.

Example 5 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-4 to optionally includewherein second filar array includes fewer second filars than the firstfilars of the first filar array.

Example 6 can include, or can optionally be combined with the subjectmatter of Examples 1-5 to optionally include wherein the braided braceincludes a coil interlaced with the first filar array.

Example 7 can include, or can optionally be combined with the subjectmatter of Examples 1-6 to optionally include wherein the coil includes acircular cross section.

Example 8 can include, or can optionally be combined with the subjectmatter of Examples 1-7 to optionally include wherein the outer sleeve isreflowed over the braid assembly, and the reflowed outer sleeve anchorsthe braided brace within the catheter body, and the reflowed outersleeve and the braided brace cooperate to structurally support the firstfilar array.

Example 9 can include, or can optionally be combined with the subjectmatter of Examples 1-8 to optionally include wherein the braid assemblyincludes a torqueable and kink-resistant braid assembly, the first filararray includes a first torqueability and a first kink-resistance, andthe braided brace includes a second kink resistance greater than thefirst kink resistance.

Example 10 can include, or can optionally be combined with the subjectmatter of Examples 1-9 to optionally include wherein the braided braceincludes a second torqueability less than the first torqueability of thefirst filar array.

Example 11 can include, or can optionally be combined with the subjectmatter of Examples 1-10 to optionally include a coil extending helicallyalong an exterior of the braid assembly.

Example 12 can include, or can optionally be combined with the subjectmatter of Examples 1-11 to optionally include wherein the braided braceincludes at least one guide recess extending helically around thecatheter body, and the coil is received in the at least one guiderecess.

Example 13 can include, or can optionally be combined with the subjectmatter of Examples 1-12 to optionally include wherein the at least oneguide recess extends along one of a proximal face or a distal face ofthe braided brace.

Example 14 can include, or can optionally be combined with the subjectmatter of Examples 1-13 to optionally include wherein the coil and thebraided brace clamp the braid assembly therebetween.

Example 15 can include, or can optionally be combined with the subjectmatter of Examples 1-14 to optionally include a catheter assemblycomprising: a catheter body extending from a catheter proximal portionto a catheter distal portion, the catheter body includes an inner liner,and an outer sleeve; a braid assembly within the catheter body andbetween the inner liner and the outer sleeve, the braid assemblyincludes: a first filar array including one or more first filarshelically extending around the catheter body in a first direction, asecond filar array including one or more second filars helicallyextending around the catheter body in a second direction opposed to thefirst direction, and wherein at least one of the first or second filararrays includes at least one guide recess helically extending with thefirst or second filars; and a coil is received in the at least one guiderecess and extends helically around the catheter body with the first orsecond filars.

Example 16 can include, or can optionally be combined with the subjectmatter of Examples 1-15 to optionally include wherein the one or moresecond filars of the second filar array have a larger dimension across afilar cross section than a smaller dimension of the one or more firstfilars of the first filar array.

Example 17 can include, or can optionally be combined with the subjectmatter of Examples 1-16 to optionally include wherein the at least oneguide recess extends along the second filar array including the largerdimension, and the at least one guide recess includes a recess depthvarying proportionally with the larger dimension.

Example 18 can include, or can optionally be combined with the subjectmatter of Examples 1-17 to optionally include wherein the one or moresecond filars include flat or ovular filars and the larger dimensionincludes one or more of width and thickness of the flat or ovularfilars.

Example 19 can include, or can optionally be combined with the subjectmatter of Examples 1-18 to optionally include wherein the one or moresecond filars include circular filars and the larger dimension includesa diameter of the circular filars.

Example 20 can include, or can optionally be combined with the subjectmatter of Examples 1-19 to optionally include wherein the coil includesa coil profile, and at least a first portion of the coil profile isreceived within the at least one guide recess.

Example 21 can include, or can optionally be combined with the subjectmatter of Examples 1-20 to optionally include wherein the coil profileincludes a second portion of the coil profile, and the second portion ofthe coil profile is received in the outer sleeve.

Example 22 can include, or can optionally be combined with the subjectmatter of Examples 1-21 to optionally include wherein the coil includesa coil profile, and at least a portion of the coil profile is receivedwithin the at least one guide recess and coextensive with a braidprofile of the braid assembly.

Example 23 can include, or can optionally be combined with the subjectmatter of Examples 1-22 to optionally include wherein the coil includesa diameter of about 0.001 to 0.010 inches.

Example 24 can include, or can optionally be combined with the subjectmatter of Examples 1-23 to optionally include wherein at least one ofthe first or second filar arrays includes: a proximal guide recessextending along a proximal face of the first or second filar array, anda distal guide recess extending along a distal face of the first orsecond filar array.

Example 25 can include, or can optionally be combined with the subjectmatter of Examples 1-24 to optionally include wherein the coil isreceived in one of the proximal or distal guide recesses.

Example 26 can include, or can optionally be combined with the subjectmatter of Examples 1-25 to optionally include wherein the coil includesa first coil and a second coil, and the first coil is received in theproximal guide recess and the second coil is received in the distalguide recess.

Example 27 can include, or can optionally be combined with the subjectmatter of Examples 1-26 to optionally include wherein the coil extendsover an exterior of the braid assembly.

Example 28 can include, or can optionally be combined with the subjectmatter of Examples 1-27 to optionally include wherein the coil extendsover an interior of the braid assembly.

Example 29 can include, or can optionally be combined with the subjectmatter of Examples 1-28 to optionally include a catheter assemblycomprising: a catheter body extending from a catheter proximal portionto a catheter distal portion, the catheter body includes: an innerliner, and an outer sleeve; and a braid assembly within the catheterbody and between the inner liner and the outer sleeve, the braidassembly includes: a first filar array including one or more firstfilars helically extending around the catheter body in a firstdirection, and a second filar array including one or more second filarshelically extending around the catheter body in a second directionopposed to the first direction.

Example 30 can include, or can optionally be combined with the subjectmatter of Examples 1-29 to optionally include wherein a first filarcount of the one or more first filars is greater than a second filarcount of the one or more second filars.

Example 31 can include, or can optionally be combined with the subjectmatter of Examples 1-30 to optionally include wherein at least a secondfilar width of the one or more second filars is greater than a firstfilar width of the one or more first filars according to the differencebetween the first and second filar counts.

Example 32 can include, or can optionally be combined with the subjectmatter of Examples 1-31 to optionally include wherein at least a secondfilar width of the one or more second filars is greater than a firstfilar width of the one or more first filars when the first filar countis greater than the second filar count.

Example 33 can include, or can optionally be combined with the subjectmatter of Examples 1-32 to optionally include wherein a first filarcount of the one or more first filars and the second filar count of theone or more second filars are at ratios including 15:1, 14:2, 13:3,12:4, 11:5, 10:6, 9:7, 8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15.

Example 34 can include, or can optionally be combined with the subjectmatter of Examples 1-33 to optionally include wherein at least a secondfilar width of the one or more second filars is greater than a firstfilar width of the one or more first filars.

Example 35 can include, or can optionally be combined with the subjectmatter of Examples 1-34 to optionally include wherein the second filarwidth is at least an order of magnitude greater than the first filarwidth.

Example 36 can include, or can optionally be combined with the subjectmatter of Examples 1-35 to optionally include wherein at least one ofthe first and second filars includes a flat or ovular cross section.

Example 37 can include, or can optionally be combined with the subjectmatter of Examples 1-36 to optionally include wherein at least one ofthe first and second filars include a thickness dimension of about0.0005 to 0.005 inches and a width dimension of about 0.001 to 0.030inches.

Example 38 can include, or can optionally be combined with the subjectmatter of Examples 1-37 to optionally include wherein the braid assemblyincludes at least one guide recess extending along one of the first orsecond filar arrays, and comprising a coil received within the at leastone guide recess.

Example 39 can include, or can optionally be combined with the subjectmatter of Examples 1-38 to optionally include wherein the coil follows ahelix of either of the first or second filar arrays according the atleast one guide recess extending the either of the first second filararrays.

Example 40 can include, or can optionally be combined with the subjectmatter of Examples 1-39 to optionally include wherein the coil includesa coil profile, and at least a portion of the coil profile is positionedin the at least one guide recess.

Example 41 can include, or can optionally be combined with the subjectmatter of Examples 1-40 to optionally include wherein the coil includesa coil profile, and at least a portion of the coil profile iscoextensive with a braid profile of the braid assembly.

Example 42 can include, or can optionally be combined with the subjectmatter of Examples 1-41 to optionally include wherein the coil includesa diameter of about 0.001 to 0.010 inches.

Example 43 can include, or can optionally be combined with the subjectmatter of Examples 1-42 to optionally include wherein at least one ofthe first or second filars of the first or second filar arrays is a coilinterlaced with the other of the second or first filar arrays.

Example 44 can include, or can optionally be combined with the subjectmatter of Examples 1-43 to optionally include wherein the coil includesa diameter of about 0.001 to 0.010 inches.

Example 45 can include, or can optionally be combined with the subjectmatter of Examples 1-44 to optionally include wherein at least one ofthe first or second filar arrays includes a braided brace interlacedwith the other of the second or first filar arrays.

Example 46 can include, or can optionally be combined with the subjectmatter of Examples 1-45 to optionally include wherein the outer sleeveis reflowed over the braid assembly, and the reflowed outer sleeveanchors the braided brace within the catheter body, and the reflowedouter sleeve and the braided brace of the first or second filar arraycooperate to structurally support the other of the second or first filararray.

Example 47 can include, or can optionally be combined with the subjectmatter of Examples 1-46 to optionally include wherein the one or morefirst filars and the one or more second filars have a picks per inch(PPI) of between 30 and 180.

Each of these non-limiting examples can stand on its own, or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which thedisclosure can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the disclosure should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

The claimed invention is:
 1. A catheter assembly comprising: a catheterbody extending from a catheter proximal portion to a catheter distalportion, the catheter body includes: an inner liner having a catheterbody inner diameter, the inner liner extending around a catheter lumen;an outer sleeve having a catheter body outer diameter; and a braidassembly within the catheter body and between the inner liner and theouter sleeve, the braid assembly includes: a first filar array includingone or more first filars helically extending along the catheter body ina first direction, wherein the one or more first filars include a firstrectangular profile of 0.003 inches in width by 0.0007 inches inthickness; and a second filar array including: a first set of secondfilars helically extending along the catheter body in a seconddirection, wherein the first set of second filars include the firstrectangular profile; and a second set of second filars helicallyextending along the catheter body in the second direction, wherein thesecond set of second filars include a second rectangular profile of0.008 inches in width by 0.002 inches in thickness; wherein the outersleeve penetrates the braid assembly and contacts the inner liner; andwherein the catheter body includes a wall thickness between the catheterbody inner and outer diameters of around 0.0040 inches.
 2. The catheterassembly of claim 1, wherein the inner liner includes an inner linerthickness of 0.00075 inches, and the outer sleeve includes an outersleeve thickness of 0.0005 inches.
 3. The catheter assembly of claim 1,wherein the braid assembly is layered over the inner liner, and theouter sleeve is layered over the braid assembly.
 4. The catheterassembly of claim 1, wherein the one or more first filars of the firstfiler array includes eight first filars; the first set of second filarsof the second filar array include four second filars; and the second setof second filars of the second filar array include four second filars.5. The catheter assembly of claim 1, wherein the first filar arrayincludes a first kink-resistance; and the second filar array includes asecond kink resistance greater than the first kink resistance.
 6. Thecatheter assembly of claim 1, wherein the second set of second filars ofthe second filar array include a braided brace with a second kinkresistance greater than a first kink resistance of the first set ofsecond filars of the second filar array.
 7. The catheter assembly ofclaim 6, wherein the braided brace with the second kink resistance isgreater than a third kink resistance of the first filar array.
 8. Thecatheter assembly of claim 6, wherein the braided brace includes four ofthe second filars with the second rectangular profile.
 9. A catheterassembly comprising: a catheter body extending from a catheter proximalportion to a catheter distal portion, the catheter body includes: aninner liner having a catheter body inner diameter, the inner linerextending around a catheter lumen; an outer sleeve having a catheterbody outer diameter; and a braid assembly within the catheter body andbetween the inner liner and the outer sleeve, the braid assemblyincludes: a first filar array including at least eight first filarshelically extending along the catheter body in a first direction,wherein the first filars include a first rectangular profile of 0.003inches in width by 0.0007 inches in thickness; and a second filar arrayincluding: a set of four filars helically extending along the catheterbody in the second direction, wherein the set of four filars include thefirst rectangular profile; and a braided brace helically extending alongthe catheter body in the second direction, wherein the braided braceincludes filars having a second rectangular profile of 0.008 inches inwidth by 0.002 inches in thickness; wherein the outer sleeve penetratesthe braid assembly and contacts the inner liner; and wherein thecatheter body includes a wall thickness between the catheter body innerand outer diameters of around 0.0040 inches.
 10. The catheter assemblyof claim 9, wherein the inner liner includes an inner liner thickness of0.00075 inches, and the outer sleeve includes an outer sleeve thicknessof 0.0005 inches.
 11. The catheter assembly of claim 9, wherein thebraid assembly is layered over the inner liner, and the outer sleeve islayered over the braid assembly.
 12. The catheter assembly of claim 9,wherein the first filar array includes a first kink-resistance; and thesecond filar array includes a second kink resistance greater than thefirst kink resistance.
 13. The catheter assembly of claim 9, wherein thebraided brace includes a second kink resistance greater than a firstkink resistance of the set of four filars of the second filar array. 14.The catheter assembly of claim 13, wherein the second kink resistance ofthe braided brace is greater than a third kink resistance of the firstfilar array.
 15. The catheter assembly of claim 9, wherein the filars ofthe braided brace includes four filars having the second rectangularprofile.